Taking a Side in the Debate over Medical Device Service

October 2017

This year, we’ve seen an even hotter-than-usual debate about the servicing of medical devices and healthcare technology, thanks in part to calls for new standards, a congressional mandate for an FDA report on the subject, and renewed interest in making data-based decisions. The discussion can get particularly heated when we talk about third-party service providers or the maintenance of imaging equipment.

During such moments, we sometimes are asked why AAMI does not advocate or lobby for one community over another, whether we are talking about hospital-based healthcare technology management (HTM) professionals, independent service organizations, or the original equipment manufacturer.

It’s a valid question for our members and friends, but it is one that ignores one of the fundamental realities about AAMI. The truth is we do have a side in this debate: AAMI stands with those who are advancing the safe and effective support and service of healthcare technology. No one camp has all the answers, nor would it be helpful to assert that any one group could—or should—be the sole provider of medical device service.

The world of modern medicine is much too complicated to think in the kind of absolutes that pit one stakeholder against another. Advocating or lobbying for one part of our membership base would undermine our strength and unique position as a neutral convener. We think lasting solutions are found when you listen to all points of view, seek common ground, and keep your eyes on the greater good: cost-effective healthcare that makes the best use of technology and improves patient outcomes.

AAMI’s objectivity helps to facilitate convening communities with different concerns in a safe environment. Compromising that approach would break trust with multiple parts of our membership, making the toughest problems we face completely intractable. Despite how the absence of group-specific advocacy can sometimes feel in the short term, the ability to work in this fashion is relied upon heavily by AAMI’s membership and stakeholders.

My belief is that every interested party in the service debate would be better served if we focused on doing what it takes to understand the risks associated with servicing medical devices and developing or adopting the processes and best practices to support mitigation of those risks. One difficulty, of course, is that relatively little data exists on the safety of medical equipment service. Certainly there have been a couple of valuable reports, notably an analysis by a trio of respected HTM experts who found an extremely low number of patient incidents tied to medical equipment maintenance omissions—specifically, an estimated range of 0.00011-0.0006 incidents per million equipment uses in 2011. That article, written by Binseng Wang and colleagues and published in BI&T in 2013, was based on an analysis of a Sentinel Events database maintained by The Joint Commission.

In general, however, legitimate questions surround the voluntary nature of much incident reporting, and we need more empirical data that is structured, organized, processed, and placed into context so that we have the best possible information on which to create actions in response.

Irrespective of that data challenge, we can agree on a basic premise: Patient safety is increasingly tied to medical devices. And, as with all technology, there are risks involved. So, what is AAMI doing? We’re taking the long view toward fully understanding the risks and mitigating them.

Our activities on the service front include the following:

We are monitoring and providing feedback as appropriate on an effort by the Medical Imaging & Technology Alliance (MITA) to develop an American National Standard for the servicing of imaging equipment. We are speaking up in support of using transparent and appropriate processes and procedures to develop it. We provided initial written feedback to MITA prior to a face-to-face meeting of the standards development group. Two AAMI staff members continue to participate in and monitor the process. The involvement of the diverse set of stakeholders engaged in this work is crucial for creating the best possible standard.

We have signed an agreement with the International Association of Medical Equipment Remarketer and Servicers (IAMERS) to help the group’s members develop new or improve their existing quality management systems (QMSs). An embrace of QMS supports quality service. All IAMERS members are expected to use quality management in their organizational structure, policies, procedures, processes, and resources. AAMI will be leveraging its QMS educational resources to assist IAMERS members in meeting their requirements for understanding and fully implementing a QMS.

A key AAMI resource dealing with medical equipment service is due for revision: ANSI/AAMI EQ56:2013, Recommended practice for a medical equipment management program. In response to AAMI member requests, regulatory changes, and significant advances in technology, the revision may include relevant QMS elements from ISO 90001. If consensus is reached, these elements will support a standard that is comprehensive and complete for the variety of organizations offering medical equipment management and maintenance services. In addition, sources of empirical patient safety data and processes for capturing it will be considered. If consensus is reached on this concept, we will have a fresh opportunity to analyze patient safety related to medical equipment management programs.

AAMI is developing an acquisition standard for health delivery organizations, one that will support the goal of establishing a consistent process and standardized set of topics to be covered in the acquisition process. Ultimately, standardization will benefit both healthcare delivery organizations and vendors. Topics may include service documentation, risk management files, processes for making purchasing decisions (including who should be involved in those decisions), depreciation schedules, monitoring of hazard alerts/product recalls, identifying technical specifications, and a standardized request for proposals (RFP) format. The standard may address some service-related questions as well.

Most importantly, we are here to serve you, regardless of your organizational or personal position on medical equipment servicing. As the AAMI staff person on point, Patrick Bernat will share any factual information we have to ensure that you stay on top of the discussions. Our most senior subject matter expert in standards, Joe Lewelling, has this as his top priority. And, please, if you need to email or call me, I’m here for you as well.

Prior to coming to AAMI, I worked with the federal government for 21 years. During that time, I never met a legislator, congressional staffer, or regulator who was interested in establishing a statute or regulation once he or she was convinced it was unnecessary. As a community, we have an opportunity to assure lawmakers that we are taking the appropriate steps to address any patient safety gaps that may exist with regard to servicing. Then, data may be collected and analyzed to show the magnitude of any remaining risk and the level of need for statutory or regulatory oversight.

All of this must play out in an atmosphere of candid and respectful discourse and debate, with a realization that the solutions can be found in our collective wisdom.